BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEGUARD NON-CORING SAFETY INFUSION SET

    MDR report key: 1900133 · Received October 22, 2010

    Report

    Report Number
    2245270-2010-00013
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 2, 2010
    Report Date
    October 22, 2010
    Manufacturer
    VYGON
    Product Code
    FPA
    PMA / PMN Number
    K013871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT # 1004176. THE TWO USED DEVICES WERE SENT TO VYGON SHORTLY AFTER THE INITIAL REPORTED EVENT, ON (B)(6) 2010. THE INVESTIGATION BY THE QA AND ENGINEERING DEPARTMENTS ARE PENDING. RESULTS WILL BE SUBMITTED IN A FOLLOW UP MDR.

    Description of Event or Problem · 1

    THERE WERE HOLES IN THE TUBING OF THE LIFEGUARD SAFETY INFUSION SET CAUSING THE INFUSED FLUID, SALINE, TO LEAK. THERE WERE TWO OCCURRENCES OF THIS AND PTS WERE NOT ADVERSELY AFFECTED IN EITHER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEGUARD NON-CORING SAFETY INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA VYGON CLG-2234 1003539

    Patients

    Seq Age Sex Outcome Treatment
    1 Other